BioXcel Therapeutics Reports Significant Revenue Decline and Increased Net Loss for June 2025

BioXcel Therapeutics, Inc. (BTI) reported product revenue of $120,000 for the three months ended June 30, 2025, a significant decrease from the $1.104 million reported for the same period in 2024. Similarly, for the six months ended June 30, 2025, product revenue was $288,000, down from $1.686 million in the prior year. The company attributed this decline primarily to reduced bulk sales, increased GPO discounts, and a decrease in commercial activities following its clinical prioritization efforts. Cost of goods sold for the three and six months ended June 30, 2025, were $107,000 and $121,000, respectively, compared to $62,000 and $141,000 for the same periods in 2024.

Operating expenses for the three months ended June 30, 2025, totaled $15.972 million, compared to $18.400 million for the same period in 2024. Research and development expenses were $10.256 million, up from $8.032 million, while selling, general, and administrative expenses decreased to $5.609 million from $9.450 million. For the six months ended June 30, 2025, operating expenses were $26.239 million, a decrease from $43.145 million in 2024. Research and development expenses decreased to $14.810 million from $19.433 million, and selling, general, and administrative expenses decreased to $11.308 million from $22.715 million. The net loss for the three months ended June 30, 2025, was $19.187 million, or $2.45 per share, compared to a net loss of $8.299 million, or $3.30 per share, for the same period in 2024. The net loss for the six months ended June 30, 2025, was $26.441 million, or $4.17 per share, compared to a net loss of $35.090 million, or $15.78 per share, for the same period in 2024.

BTI's strategic developments included a workforce reduction of approximately 15% on May 8, 2024, and an additional 28% reduction on September 17, 2024, as part of its clinical prioritization efforts. These actions were aimed at preserving cash and focusing on core clinical programs, particularly the development of BXCL501. The company also continued to evaluate strategic options for its subsidiary, OnkosXcel Therapeutics, LLC, which focuses on immuno-oncology assets. As of August 11, 2025, the number of outstanding shares of the registrant’s common stock, $0.001 par value per share, was 14,556,743.

Key operational developments included the ongoing SERENITY At-Home pivotal Phase 3 safety trial for BXCL501, intended to support a supplemental new drug application (sNDA) submission to potentially expand the label of IGALMI® for outpatient use. The company announced full enrollment in the trial on May 12, 2025, and completion of the last patient last visit on August 1, 2025, with topline data expected in August 2025. BTI also continued to advance plans for the TRANQUILITY In-Care Phase 3 trial, designed to evaluate the efficacy and safety of BXCL501 for agitation associated with Alzheimer’s dementia, pending funding. The company is also supporting investigator-sponsored trials (ISTs) for BXCL501 in opioid use disorder (OUD), alcohol use disorder (AUD) with comorbid post-traumatic stress disorder (PTSD), and acute stress disorder (ASD).

Looking ahead, BTI's management plans to improve the company’s liquidity and reduce its operating expenses and capital requirements by pursuing additional capital through the sale of equity securities, third-party investments in OnkosXcel, debt financing, collaborations with potential partners, and further reductions in overhead and headcount. However, the company acknowledges substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance date of the financial statements, citing its history of significant losses, negative cash flows, and dependence on additional financing.